A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

NCT02783690 | Completed Phase 2 Results DMC

• 3 other identifiers: 15-006137MC1631NCI-2017-02362
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Complication Rate

  Will be defined as the percentage of women randomized who develop one or more of the following events: grade 3 or higher late adverse events; unplanned surgical intervention (not including planned serial fat grafting) in patients who undergo mastectomy with reconstruction.

  24 months

Secondary Outcomes (10)

• Incidence of Acute Adverse Events

  5 years

• Incidence of Late Adverse Events

  5 years

• Reconstruction Failure

  5 years

• Quality of Life - Breast Cancer Outcomes

  5 years

• Cosmesis

  baseline, 2 years, and 5 years

Study Arms (2)

Conventional Fractionation

NO INTERVENTION

50.0 Gy (RBE) in 25 daily fractions

Hypofractionation

EXPERIMENTAL

40 Gy (RBE) in 15 daily fractions

Radiation: Hypofractionation

Interventions

Hypofractionation RADIATION

40 Gy (RBE) in 15 daily fractions

Hypofractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned.
• pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0 Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
• ECOG Performance Status (PS) 0 to 2. (Appendix I).
• Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
• Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy.
• Note: Breast implants and expanders allowed
• Able to and provides IRB approved study specific written informed consent
• Ability to complete questionnaire (s) by themselves or with assistance
• Able to complete all mandatory tests listed in section 4.0
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Willing to provide tissue and blood samples for correlative research purposes.
• Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136
• Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number 15-007443

You may not qualify if:

• Medical contraindication to receipt of radiotherapy.
• Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
• Active systemic lupus or scleroderma.
• Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
• Prior receipt of ipsilateral breast or chest wall radiation that would result in significant overlap of radiation therapy fields. Prior contralateral radiotherapy for breast cancer is allowed.
• Positive margins after definitive surgery
• History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
• Inflammatory breast cancer
• Recurrent Breast Cancer
• Boosts to the chest wall after mastectomy. Nodal boosts are allowed.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8.

  PMID: 37696281 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Robert Mutter, M.D.
• Organization: Mayo Clinic

mutter.robert@mayo.edu

507-284-2511

Study Officials

• Robert W. Mutter, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 26, 2016
• Study Start: May 18, 2016
• Primary Completion: October 21, 2020
• Study Completion: November 18, 2023
• Last Updated: December 4, 2025
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (2)